FDAClass IIFebruary 22, 2023

HydroPICC 4Fr Single Lumen recall

HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002

Why was HydroPICC 4Fr Single Lumen recalled?

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: (01)00862559000463; Lot Number: 11389279, 11391525

Product
HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Recalling firm
Access Vascular, Inc
Quantity
N/A
Distribution
US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
Recall date
February 22, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls